Indications for SYNJARDY XR:
Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes when treatment with both empagliflozin and metformin is appropriate.
Limitations of Use:
Not for treating type 1 diabetes or diabetic ketoacidosis.
See full labeling. Swallow whole. Individualize. Take once daily with morning meal; increase dose gradually. Max daily dose: 25mg/2000mg.
<18yrs: not established.
SYNJARDY XR Contraindications:
Moderate to severe renal impairment (eGFR <45mL/min/1.73m2), ESRD, or on dialysis. Metabolic acidosis, diabetic ketoacidosis.
SYNJARDY XR Warnings/Precautions:
Increased risk of metformin-associated lactic acidosis in renal or hepatic impairment, concomitant use of certain drugs (eg, cationic drugs), ≥65yrs of age, undergoing radiological contrast study, surgery and other procedures, hypoxic states, and excessive alcohol intake; discontinue if lactic acidosis is suspected. Discontinue at time of, or prior to intravascular iodinated contrast imaging in patients with eGFR 45–60mL/min/1.73m2, history of hepatic impairment, alcoholism, heart failure, or will be given intra-arterial contrast; reevaluate eGFR 48hrs after procedure and restart therapy if renally stable. Correct volume depletion before initiating. Monitor for symptomatic hypotension in renal impairment, elderly, low systolic BP, or those on diuretics. Assess for ketoacidosis in presence of signs/symptoms of metabolic acidosis, regardless of blood glucose levels; discontinue if suspected, evaluate and treat; consider risk factors before initiation (eg, pancreatic insulin deficiency, caloric restriction, alcohol abuse). Consider temporarily discontinuing prior to scheduled surgery (for ≥3 days) or other clinical situations (eg, prolonged fasting due to illness or post-surgery). Assess renal function prior to starting and monitor periodically thereafter; more frequently in elderly or if eGFR <60mL/min/1.73m2. Risk of acute kidney injury in hypovolemia, chronic renal insufficiency, CHF, and concomitant drugs (eg, diuretics, ACEIs, ARBs, NSAIDs). Consider temporarily discontinuing in reduced oral intake or fluid losses; monitor for acute kidney injury; discontinue and treat if occurs. Elderly, debilitated, uncompensated strenuous exercise, malnourished or deficient caloric intake, adrenal or pituitary insufficiency, or alcohol intoxication: increased risk of hypoglycemia. Necrotizing fasciitis of the perineum (Fournier's gangrene); discontinue and treat immediately if suspected; use alternative antidiabetic. Increased risk of genital mycotic infections, UTIs, or elevated LDL-C; monitor and treat as appropriate. Discontinue if hypersensitivity reaction occurs; treat promptly and monitor until resolve. Measure hematologic parameters annually (esp. serum Vit. B12 in susceptible patients). Hepatic impairment: avoid. Pregnancy (during 2nd & 3rd trimesters), nursing mothers: not recommended.
SYNJARDY XR Classification:
Sodium-glucose co-transporter 2 (SGLT2) inhibitor + biguanide.
SYNJARDY XR Interactions:
Increased risk of lactic acidosis with topiramate, other carbonic anhydrase inhibitors (eg, zonisamide, acetazolamide, dichlorphenamide); monitor. Concomitant cationic drugs that interfere with renal tubular transport systems (eg, ranolazine, vandetanib, dolutegravir, cimetidine) may increase metformin levels; monitor. Avoid excessive alcohol. Diuretics, steroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, sympathomimetics, nicotinic acid, CCBs, and isoniazid may cause hyperglycemia. Greater potential for volume depletion with concomitant diuretics. May need a lower dose of concomitant insulin or insulin secretagogue to reduce risk of hypoglycemia. β-blockers may mask hypoglycemia. May cause false (+) urine glucose tests or unreliable measurements of 1, 5-AG assay; use alternative methods to monitor glycemic control.
UTIs, female genital mycotic infections, diarrhea, nausea/vomiting, flatulence, abdominal discomfort, indigestion, asthenia, headache; hypotension, ketoacidosis, renal impairment, urosepsis, pyelonephritis, angioedema; rare: Fournier's gangrene.
Generic Drug Availability:
Tabs—60, 180; XR tabs 5mg/1000mg, 12.5mg/1000mg—60, 180; 10mg/1000mg, 25mg/1000mg—30, 90